Manager Quality Assurance

Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, enable life-saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services, and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

About the Role

This position must be independent from production-associated activities to meet the cGMP definition of an independent Quality Unit and function in review, approval, and release tasks as defined by cGMP regulations. Responsible for establishing and implementing effective Quality systems to meet or exceed cGMP requirements. Ensures the activities and controls used to determine the accuracy and reliability of personnel, equipment, reagents, operations, and release or rejection of final product in the manufacturing of biomaterial products, including their testing.

Responsibilities

• Ensure the center is “inspection ready” at all times by managing adherence to Standard Operating Procedures (SOPs), the organization’s QMS, compliance policies, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery, and appropriate remediation.
• Prepare regular reports to Management and corporate quality management regarding the state of quality and systems at the Center.
• Function as the responsible Quality Assurance reviewer to approve or reject final products before shipping, batch records, quarantine releases, rework, destruction, and associated documentation such as Certificates of Analyses.
• Manage the site Quality Assurance program, including but not limited to calibration management, monitoring compliance with defined processes (e.g., sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of KPIs, root cause and failure mode impact assessment, and change management).
• Demonstrate working knowledge of the change management process and appropriately raise ideas for consideration locally and upward to quality and Center management.
• Receive and provide feedback to staff on observations leading to improved adherence to cGMP regulations. Report concerns or deficiencies to Center personnel and/or Center management immediately.
• Review operations staff’s RCA, corrective actions, and effectiveness checks to resolve audit observations and other non-compliance issues or deficiencies.
• Lead and function as the key Quality representative for site supplier, customer, and regulatory audits. Lead the Center’s review of findings, coordination of Corrective and Preventive Actions (CAPA), if needed, and successful closure of audits in a timely fashion.
• Utilize quality tools and applications to facilitate understanding of issues and documentation.
• Conduct routine audits of internal procedures and documentation, as necessary.
• Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance and ensure Center management does the same.
• Comply with all Federal, State, and local regulatory laws, standards, and guidelines.
• Maintain confidentiality of all personnel, contributor, and Center information.
• Monitor CAPAs and effectiveness checks to ensure issues are resolved.
• Perform other duties as assigned.

Qualifications

• Bachelor's Degree required.
• Minimum of 7-9 years of experience, with at least six years of QA oversight of biological manufacturing operations, utilizing a risk-based approach to biologic material manufacturing.
• Working knowledge and experience practicing under a QMS preferred.
• Two or more years performing as a responsible cGMP Quality sign-off for a regulated product preferred.
• Working knowledge of 21 CFR 210, 211, and 820 preferred.
• Demonstrated ability to work with remote resources across multiple sites preferred.

Skills

• Experience with batch record review, results outside of specifications, and CAPA investigations.
• Experienced with both Quality and production-related documentation, line clearances, and status control of raw materials and finished product, approval of Certificates of Analysis (C of A’s), quarantine, and release of in-process and finished goods.
• Internal and external audit experience; lead audit support preferred.
• Strong understanding of FDA regulations as they apply to blood products or pharmaceuticals.
• Positive, enthusiastic, and customer service-oriented interpersonal skills.
• Ability to work as part of a high-performing team and collaborate effectively with staff at all levels, establishing highly functional relationships within and outside the company.
• Excellent technical writing and verbal communication skills.
• Domestic travel (~10%) as needed.
• Strong oral, written, and listening skills.
• Ability to assess priorities and successfully manage workload to timelines.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Understanding of basic scientific/technical concepts and ability to analyze moderate to complex data, gleaning basic information from the data.
• Previous experience with electronic quality systems such as document control, training, and change control preferred.

Tools and Technology

• Personal Computer (desktop, laptop, tablet) required.
• General office equipment (computer, printer, fax, copy machine) required.
• Microsoft Suite (Word, Excel, PowerPoint) required.

Pay

The target salary for this position is $100,000 annually. The target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education, experience, skills, and performance.

Benefits

Versiti provides a comprehensive benefits package based on job classification. Full-time regular employees are eligible for:

• Medical, Dental, and Vision Plans
• Paid Time Off (PTO) and Holidays
• Short- and Long-term disability
• Life insurance
• 7% match dollar-for-dollar 401(k)
• Voluntary programs
• Discount programs